MOUNTAIN VIEW, Calif., Sept. 9 /PRNewswire-FirstCall/ --
VIVUS,Inc. today announced positive results from two final, phase 3
pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303),
evaluating the safety and efficacy of Qnexa(TM), an investigational
drug, in more than 3,750 patients across 93 sites. The EQUIP and
CONQUER studies met all primary endpoints by demonstrating
statistically significant weight loss with all three doses of
Qnexa, as compared to placebo. Patients taking Qnexa also achieved
significant improvements in cardiovascular and metabolic risk
factors including blood pressure, lipid levels, and type 2
diabetes.

Highlights from the EQUIP and CONQUER studies include:

"The outstanding results from the EQUIP and CONQUER studies, in
addition to the results from EQUATE that were reported late last
year, confirm the positive effect of Qnexa and underscore the
important role this therapy may play in the lives of patients
battling obesity and related co-morbidities, if approved by the
FDA," stated Leland Wilson, president and chief executive officer
of VIVUS. "The results of the phase 3 program, designed and
executed after Special Protocol Assessments were completed by the
FDA, exceed the FDA benchmarks for clinically significant weight
loss. The results support the company's plan to file a New Drug
Application with the FDA by the end of 2009 and submit the results
from the studies for publication in peer-reviewed journals. We
believe these results may provide a compelling opportunity for
global pharmaceutical companies, and we intend to initiate
partnering discussions now that we have the full data set in
hand."

Wilson added, "We are proud of the results of our Qnexa phase 3
program, and I would like to thank Dr. Thomas Najarian, the
inventor of Qnexa, the entire development team at VIVUS, Dr. David
Orloff and his staff at Medpace, the clinical research organization
that managed these studies, and the clinical investigators and
patients who participated in the Qnexa clinical trials."

Qnexa is a proprietary formulation and unique dosing regimen
that combines two well known pharmaceutical therapies - phentermine
and topiramate - to create a novel, patented therapy. The phase 3
program evaluated three doses of Qnexa (numbers reflect milligrams
of phentermine and controlled release topiramate,
respectively):

"The weight loss observed with Qnexa in these two one-year,
double-blind, randomized trials far exceeds the weight loss
observed for other agents reported in literature," said Kishore
Gadde, MD, director of obesity clinical trials at Duke University
and a lead investigator. "The efficacy and safety results confirm
the earlier findings of our phase 2 study, which showed a very good
efficacy and benefit/risk profile. Importantly, the medical
benefits of this treatment in reducing the risk of weight-related
co-morbidities such as hypertension, diabetes, and dyslipidemia
could establish Qnexa as a major advancement in the management of
obesity."

The EQUIP study included 1,267 morbidly obese patients (1,050
females and 217 males) across 93 centers in the United States. The
average baseline BMI of the study population was 42.1 kg/m(2) and
baseline weight was 256 pounds. Patients had a 4-week dose
titration period followed by 52 weeks of treatment. The study was a
randomized, double-blind, placebo-controlled, 3-arm, prospective
trial with patients randomized to receive once-a-day treatment with
low-dose Qnexa, full-dose Qnexa or placebo. Patients were asked to
follow a hypocaloric diet representing a 500-calorie/day deficit
and advised to implement a simple lifestyle modification program.
Results from the study are as follows:

The CONQUER study included 2,487 overweight and obese patients
(1,737 females and 750 males) with high blood pressure, high
cholesterol or type 2 diabetes across 93 centers in the United
States. The average baseline BMI of the study population was 36.6
kg/ m2 and baseline weight was 227 pounds. Patients had a 4-week
dose titration period followed by 52 weeks of treatment. The study
was a randomized, double-blind, placebo-controlled, 3-arm,
prospective trial with patients randomized to receive once-a-day
treatment with mid-dose Qnexa, full-dose Qnexa or placebo. Patients
were asked to follow a hypocaloric diet representing a
500-calorie/day deficit and advised to implement a simple lifestyle
modification program. Results from the study are as follows:

Across both 56-week studies comprised of more than 3,750
patients, the most commonly reported side effects were dry mouth,
tingling, constipation, altered taste and insomnia. Monthly
assessments using prospective psychometric instruments in
accordance with FDA's guidance showed no signal for suicidality
risk. There were no suicide attempts or suicidal behaviors, and
there was no signal for suicidal ideation across all treatment
groups including placebo. Depression or depressed mood adverse
events of a moderate to severe nature were less than 2% and were
similar among patients in the Qnexa and placebo groups. Overall,
depression scores, quality of life including self esteem and
general health significantly improved for patients on Qnexa.

"I have seen dramatic and sustained weight loss with Qnexa as
well as notable improvements in cardiovascular risk factors,
diabetes, emotional well being and quality of life in my patients,"
commented Michelle Look, M.D., FAAFP, of the San Diego Sports
Medicine and Family Health Center and a lead investigator in the
studies. "What is so striking for me is how many of my patients
were able to achieve weight loss with Qnexa for the first time
after many years of battling weight problems without success. The
excellent tolerability of Qnexa allowed patients to stay on therapy
for a year, as evidenced by the strong completer rates."

VIVUS completed a thorough QT prolongation (TQT) study
evaluating subjects taking Qnexa. The study was completed with no
signal for QT prolongation. Subjects taking Qnexa also underwent
complex and extensive cognitive and psychomotor testing using
validated, FDA accepted testing methodologies. There was no
clinically significant change in overall cognitive function or
effect on psychomotor skills seen in patients taking Qnexa.

"These data are significant, and when coupled with my own
experience treating patients with Qnexa, clearly demonstrate that
it is one of the promising pharmaceutical therapies in development
to assist patients in achieving significant weight loss," stated
Louis Aronne, MD, Clinical Professor of Medicine and Director of
the Comprehensive Weight Control Program at New York-Presbyterian
Hospital/Weill Cornell Medical Center and one of the investigators
involved in the clinical trials. "People with weight problems have
a truly biologic disease, and we are in desperate need of more
options and effective tools to help our patients combat this
disease and the other serious medical conditions that arise as a
result of weight gain. I am encouraged by the efficacy and safety
seen in these late stage Qnexa trials."

As previously announced, VIVUS will hold a conference call to
discuss these results today, September 09, 2009, 2009, beginning at
8:00 a.m. Eastern Time. You can listen to this call by dialing toll
free 1-800-967-7185, or 1-719-325-2352. A 30-day archive of the
call can be accessed at .

To access the webcast of this event, please visit: VIVUS'
Investors site at http://ir.vivus.com/events.cfm.
Replay will also be available on demand from the website at the
conclusion of the program.

Qnexa (Q-NEX-uh) is a once-a-day, proprietary, oral,
controlled-release formulation of low dose phentermine and
topiramate, which is believed to address both appetite and satiety
- the two main mechanisms that impact eating behavior - in one
capsule. Qnexa, an investigational drug, is being developed to
address weight loss. In phase 2 and 3 clinical data to date, Qnexa
has demonstrated significant weight loss, glycemic control, and
improvement in cardiovascular risk factors.

More than 300 million people worldwide and approximately 30
percent of American adults (more than 60 million people) are obese,
a chronic condition defined by having excess body fat. As the
second leading cause of preventable death, obesity directly
contributes to numerous life-threatening conditions including
diabetes, cardiovascular disease, hypertension and stroke. Experts
agree that even a modest weight loss of five percent of weight,
maintained over time, can bring significant health benefits by
lowering blood pressure and reducing the risk of diabetes and heart
disease.

VIVUS is a biopharmaceutical company developing innovative,
next-generation therapies to address unmet needs in obesity,
diabetes and sexual health. The company's lead product in clinical
development, Qnexa(TM), has recently completed phase 3 clinical
trials for the treatment of obesity. Qnexa is also in phase 2
clinical development for the treatment of type 2 diabetes. In the
area of sexual health, VIVUS is in phase 3 development with
avanafil, a potentially best-in-class PDE5 inhibitor, and in phase
2 development of Luramist(TM) for the treatment of hypoactive
sexual desire disorder (HSDD) in women. MUSE(R) (alprostadil), a
first generation therapy for the treatment of ED, is already on the
market and generating revenue for VIVUS. For more information about
the company, please visit .

Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified by the use of
forward-looking words such as "anticipate," "believe," "forecast,"
"estimated" and "intend," among others. These forward-looking
statements are based on VIVUS' current expectations and actual
results could differ materially. There are a number of factors that
could cause actual events to differ materially from those indicated
by such forward-looking statements. These factors include, but are
not limited to, substantial competition; uncertainties of patent
protection and litigation; uncertainties of government or third
party payer reimbursement; reliance on sole source suppliers;
limited sales and marketing efforts and dependence upon third
parties; risks related to the development of innovative products;
and risks related to failure to obtain FDA clearances or approvals
and noncompliance with FDA regulations. As with any pharmaceutical
under development, there are significant risks in the development,
regulatory approval and commercialization of new products. There
are no guarantees that future clinical studies discussed in this
press release will be completed or successful or that any product
will receive regulatory approval for any indication or prove to be
commercially successful. VIVUS does not undertake an obligation to
update or revise any forward-looking statement. Investors should
read the risk factors set forth in VIVUS' Form 10-K for the year
ended December 31, 2008 and periodic reports filed with the
Securities and Exchange Commission.

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